HR HTC

GUDID 20763000558332

CARTRIDGE 402-07 HR HTC BXD 20BX

MEDTRONIC, INC.

Heparin anti-Xa IVD, kit, chromogenic
Primary Device ID20763000558332
NIH Device Record Keya0e995c6-9d0d-46f9-8acb-ee1a0ff9e79f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHR HTC
Version Model Number402-07
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000558338 [Primary]
GS120763000558332 [Package]
Contains: 00763000558338
Package: PK [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JBPACTIVATED WHOLE BLOOD CLOTTING TIME

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-03
Device Publish Date2026-02-23

Devices Manufactured by MEDTRONIC, INC.

20763000558332 - HR HTC2026-03-03CARTRIDGE 402-07 HR HTC BXD 20BX
20763000558332 - HR HTC2026-03-03 CARTRIDGE 402-07 HR HTC BXD 20BX
00199150003709 - Sphere-9™ Catheter2026-03-02 CATHETER AFR-00001 SPHERE 9 US GAL
20763000558189 - CLOTtrac™2026-03-02 CONTROL 550-01 CLOTTRAC CWB
20763000558196 - CLOTtrac™2026-03-02 CONTROL 550-07 CLOTTRAC HR 15BX
20763000558202 - CLOTtrac™2026-03-02 CONT 550-08 CLOTTRAC HR ABN BXD ASY
20763000558219 - CLOTtrac™2026-03-02 CONT 550-09 CLOTTRAC LR ABN BXD ASY
20763000558226 - CLOTtrac™2026-03-02 CONT 550-10 CLOTTRAC RACT ABN
20763000558233 - CLOTtrac™2026-03-02 CONTROL 550-12 CLOTTRAC HTC

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